10-Years Follow-up of the EXAMINATION Trial (EXAMINAT10N)

Hospital Clinic of Barcelona

Status: Completed

Conditions: Infarction; ST Elevation Myocardial Infarction; Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Heart Disease; Necrosis

Treatments: Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm); Drug: Everolimus Eluting Coronary Stent System

Study type: Observational

Funder types: Other

Identifiers

NCT04462315

HCB/2018/0906

Details and patient eligibility

About

The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.

Enrollment: 1,498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were enrolled in the EXAMINATION trial (NCT00828087).

Exclusion criteria

• None.

Trial design

1,498 participants in 2 patient groups

Everolimus Arm

Description:

Everolimus Eluting Coronary Stent System

Treatment:

Drug: Everolimus Eluting Coronary Stent System

Non-drug eluting stent Arm

Description:

Cobalt chromium balloon-expandable stent

Treatment:

Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)